Opportunities and insights from pharmaceutical companies on the current use of new approach methodologies in nonclinical safety assessment.

Sharing New Approach Methodology (NAM)-based regulatory experiences is crucial for improving human risk assessment and reducing animal use in drug safety testing. To foster broader adoption, the Biotechnology Innovation Organization surveyed companies about NAM usage and collected case studies showcasing NAM-based regulatory filings for biotherapeutics, where NAMs replaced large animal studies for safety assessment. These scientifically justified approaches were generally accepted by global health authorities, particularly in the context of species relevance limitations, prior target modulation experience, and/or when addressing severe disease.

Contemporary outcomes for robotic radical cystectomy and intracorporeal neobladder urinary diversion.

Introduction: Widespread adoption of robotic-assisted radical cystectomy (RARC) with totally intracorporeal neobladder urinary diversion (UD) has not been achieved, and there is a dearth of literature exploring its short-term and long-term safety. We aim to present perioperative, complications, and oncologic outcomes for this procedure.

Materials And Methods: Data from patients who underwent RARC with intracorporeal neobladder UD for bladder cancer between 2003 and 2022 from our multi-institutional cohort was prospectively collected.

Pelvic organ-sparing robot-assisted radical cystectomy in women with bladder cancer.

Objectives: To investigate the oncological and complication outcomes in women who have undergone pelvic organ-sparing robot-assisted radical cystectomy (RARC).

Patients And Methods: We conducted a retrospective, multicentre cohort study of women with bladder cancer undergoing RARC with intracorporeal urinary diversion. The primary outcomes were overall survival (OS) and cancer-specific survival (CSS), and secondary outcomes were 30- and 90-day high-grade complications in patients undergoing organ-sparing RARC vs non-organ-sparing RARC.

Shoulder Musculoskeletal Disorder Rehabilitation Using a Robotic Device Based on Electromyography (EMG) Biofeedback: A Retrospective Cohort Study.

: While shoulder injuries represent the musculoskeletal disorders (MSDs) most encountered in physical therapy, there is no consensus on their management. In attempts to provide standardized and personalized treatment, a robotic-assisted device combined with EMG biofeedback specifically dedicated to shoulder MSDs was developed. This study aimed to determine the efficacy of an 8-week rehabilitation program (3 sessions a week) using a robotic-assisted device combined with EMG biofeedback (RA-EMG group) in comparison with a conventional program (CONV group) in patients presenting with shoulder MSDs.

Long-term multicentre analysis of robot-assisted radical cystectomy for non-muscle-invasive bladder cancer.

Objective: To evaluate the 12-year survival outcomes of patients with non-muscle-invasive bladder cancer (NMIBC) who underwent robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD), focusing on those upstaged to ≥pT2 or with node-positive disease.

Materials And Methods: A multicentre, prospectively maintained database (2004-2022) was reviewed to identify patients who had undergone RARC. Univariable and multivariable models were used to assess upstaging (≥pT2, ≥pN1), and Kaplan-Meier curves were used to predict cancer-specific survival (CSS) and overall survival (OS).